Turkey Catching Up with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation

Turkey has been swiftly aligning its chemical regulatory system to that of the European Union (EU) since its EU membership negotiations commenced in 2005. KKDIK, described below, is Turkey’s new chemical regulation, currently in draft. Widely referred to as Turkey REACH, KKDIK will further Turkey’s vision of enacting EU REACH-like legislation. It is available in Turkish online.

The name is taken from the first letters of Registration (Kaydı), Evaluation (Değerlendirilmesi), Authorization (İzni) and Restriction (Kısıtlanması) of Chemicals (Kimyasalların). KKDIK has been drafted by the Ministry of Environment and Urbanization (MoEU), which is the Turkish Competent Authority responsible for its implementation and enforcement.

Turkey’s previous Chemical Inventory Control Regulation is best regarded as a scaled down version of EU REACH, whereas KKDIK is more comparable in many respects. Turkey has legislation in place addressing the classification, labelling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations.

Under KKDIK:

• The registrant must be the Importer, Manufacturer, or an Only Representative (OR) based within Turkey representing an overseas company;
   
• The responsibilities of ORs are similar to those under EU REACH;
   
• A registration must be carried out for all substances imported into or manufactured in Turkey in quantities greater than or equal to one tonne per annum;
   
• Registration will be a mandatory requirement as the “no data, no market” rule is incorporated in KKDIK in the same way as in the EU;
   
• A full EU REACH-type registration dossier is required;
   
• Companies can apply for and be granted time limited authorizations;
   
• The restriction process does not foresee any exceptions for continued use of substances presenting unacceptable risk to human health or the environment;
   
• A registration is to be conducted between December 31, 2015, and December 31, 2018, for all substances imported into or manufactured in Turkey before December 31, 2018. There is no separation of deadlines based upon tonnage band or hazard classification;
   
• After the December 31, 2018, deadline, all new substances imported into or manufactured in Turkey must have a registration in place before manufacture or import can occur;
   
• Enforcement is to be controlled by compliance checks and dossier evaluations by MoEU;
   
• Data sharing will take place through Substance Information Exchange Forums (SIEF);
   
• Authorization and restriction processes are established to control known chemicals of concern; carinogenic, mutagenic, and reprotoxic substances (CMR); persistent, bioaccumulative, and toxic (PBT) substances; and very persistent and very bioaccumulative (vPvB) substances. A risk-based substance evaluation process is in place; and
   
• Risk assessment must be conducted by a certified risk assessor.

Discussion

The classification and labelling notifications for existing hazardous substances were completed by June 1, 2015. The final step in the process is to enact KKDIK; this is still a work in progress. KKDIK is expected to be prepared in final and enter into force in the next six months. This timeline has been delayed from the original deadline of the end of 2015.

Once KKDIK is fully implemented, Turkey will have in place a complex and complete system requiring companies to respond with continuous monitoring of the various processes and sub-processes to keep track of their substances. This will be challenging for many working with chemicals in Turkey as important documentation will be mostly available only in Turkish at the time it is required for decision-making.

SIEFs established under the scope of EU REACH will need to consider modifications to the SIEF agreements to be able to use data compiled for EU REACH dossiers for KKDIK as well. It is anticipated that this will give rise to informative discussions on data sharing principles.

Turkey’s CLP Regulation (SEA) is now effectively incorporated in the Turkish chemical control system. SEA has been implemented for substances since June 1, 2015. SEA-compliant classification will be obligatory for mixtures as of June 1, 2016. All mixture products classified as hazardous that are placed on the Turkish market in accordance with SEA must be labelled accordingly by June 1, 2016. Products must have Turkish labels, including hazard pictograms and the correct Turkish signal word. Additionally, products must have hazard and precautionary statements as defined in the Annexes of the Turkish SEA regulation. Neglecting SEA labelling gives rise to severe penalties and sanctions.

When KKDIK and SEA are seen in conjunction with Turkey’s 2014 SDS Regulation (GBF), that requires SDSs to be prepared in Turkish by certified Turkish experts, it is apparent that substantial efforts will be required of local and international companies, and everyone else working in the chemical regulatory sector in Turkey, to keep up with its rapidly evolving chemical regulations.

Since REACH’s inception, The Acta Group (Acta^®) professionals have actively assessed the legislation and its implications, and have prepared clients for its requirements and those of the emerging REACH-like regulatory systems around the world. From offices in North America, Europe, and Asia, Acta professionals have the technical and regulatory know-how, the commercial sense, and the strategic resources to help companies develop and market chemical-based products successfully worldwide, including in Turkey. Visit Acta’s website for more information about Global Chemical Notification Programs and Chemical Regulation under REACH.

If you have specific questions about how best to ensure your compliance obligations under KKDIK are met, call or e-mail Zameer Qureshi at +44(0)7496272129 or zqureshi@actagroupeu.com.